Metipranolol API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Metipranolol API

Metipranolol is a non-selective beta-adrenergic receptor blocker used primarily as an ophthalmic medicine for reducing intraocular pressure in glaucoma. It blocks both β1- and β2-adrenergic receptors and is classified as a beta-blocker.

Metipranolol is available as the active pharmaceutical ingredient and as Metipranolol Hydrochloride, the hydrochloride salt used in pharmaceutical preparations.

Metipranolol API Manufacturer in India

Metipranolol is a specialized ophthalmic and cardiovascular pharmaceutical API used in pharmaceutical formulation and research.

Quality control should address identity, assay, related substances, water content, residual solvents, elemental impurities and stereochemical characteristics according to the applicable pharmacopoeial or validated manufacturer specification.

Chemical Information

CAS Number: 22664-55-7
Molecular Formula: C17H27NO4
Molecular Weight: 309.40 g/mol
Metipranolol Hydrochloride CAS: 36592-77-5
Metipranolol Hydrochloride Molecular Formula: C17H28ClNO4
Metipranolol Hydrochloride Molecular Weight: 345.87 g/mol

Drug Class: Non-selective Beta-Adrenergic Blocker
Therapeutic Class: Beta-Blocker / Antiglaucoma Agent
Therapeutic Area: Ophthalmology / Cardiovascular
Molecule Type: Synthetic Small Molecule
Stereochemistry: Racemic; 1 defined stereocenter

Mechanism of Action

Metipranolol is a non-selective β-adrenergic receptor antagonist. By blocking β-adrenergic receptors, particularly in the eye, it reduces aqueous humor production and consequently lowers intraocular pressure.

Pharmaceutical Applications

Metipranolol is associated with:

  • Open-angle glaucoma
  • Ocular hypertension
  • Reduction of intraocular pressure
  • Ophthalmic pharmaceutical formulations
  • Beta-blocker research
  • Adrenergic receptor pharmacology

Dosage Form Applications

Metipranolol hydrochloride has been used primarily in ophthalmic preparations, including eye drops and other topical ocular formulations.

Physical Characteristics

Metipranolol is a solid pharmaceutical compound. The British Pharmacopoeia supplies metipranolol as a pharmaceutical reference standard.

Manufacturing Process

A controlled Metipranolol API manufacturing process may involve:

  1. Qualification of starting materials
  2. Preparation of substituted phenoxy intermediates
  3. Controlled synthesis of the propanolamine side chain
  4. Esterification / acetylation
  5. Purification
  6. Salt formation where applicable
  7. Crystallization
  8. Filtration
  9. Controlled drying
  10. Final analytical testing
  11. Pharmaceutical-grade packaging

Quality Control Testing

Typical Metipranolol API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay
  • Related substances
  • Water content
  • Residual solvents
  • Elemental impurities
  • Optical / stereochemical purity
  • Residue on ignition
  • Stability testing

Storage

Store Metipranolol API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.

Pharmaceutical Research

Metipranolol is relevant to research involving:

  • β-adrenergic receptors
  • Non-selective beta-blockers
  • Intraocular pressure
  • Glaucoma pharmacology
  • Ophthalmic drug development
  • Adrenergic receptor antagonists
  • Cardiovascular pharmacology

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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